Active — Not RecruitingNot Applicable

AlloSure Lung Assessment and Metagenomics Outcomes Study

United States550 participantsStarted 2021-10-29

Plain-language summary

ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant. This study aims to evaluate the diagnostic performance characteristics of AlloSure Lung (dd-cfDNA) to detect a spectrum of rejection (ACR, AMR) and allograft infection (Bacterial, Viral, Fungal, Mycobacterial, Parasitic).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Unilateral or Bilateral, deceased-donor, initial or re-transplant
✓. ≤ 90 days post-transplant
✓. Ability to understand and provide informed consent and adhere to laboratory surveillance schedule
✓. Patients who have LungCare initiated within 30 days of signing the informed consent form

Exclusion criteria

✕. Multi-organ transplants
✕. Pregnancy
✕. Active malignancy

What they're measuring

ALAD

Timeframe: 1 year post-transplant

Trial details

NCT IDNCT05050955

SponsorCareDx

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2028-12-31

View on ClinicalTrials.gov More Lung Transplant Infection trials